Clearance Summary
MICROCAP PLUS/NPB-75 received FDA 510(k) clearance under submission number K024300, sponsored by Oridion Medical 1987 , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-04-03.
- Submission: K024300
- Applicant / Sponsor: Oridion Medical 1987 , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2003-04-03
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.